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Last Updated: April 25, 2024

Claims for Patent: 8,795,634

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Summary for Patent: 8,795,634

Title:	Absorption of therapeutic agents across mucosal membranes or the skin
Abstract:	Absorption of a therapeutic agent across a mucosal membrane or the skin can be enhanced using an absorption enhancer comprising a hydroxy fatty acid ester of polyethylene glycol.
Inventor(s):	Illum; Lisbeth (Nottingham, GB), Jordan; Faron Michael (Coalville, GB), Lewis; Andrew Lester (Nottingham, GB)
Assignee:	Critical Pharmaceuticals Limited (Nottingham, Nottinghamshire, GB)
Application Number:	13/063,411
Patent Claims:	1. A pharmaceutical composition comprising: a therapeutic agent selected from the group consisting of growth hormone and parathyroid hormone; and an absorption enhancer comprising polyethylene glycol 660 hydroxy fatty acid ester; wherein the composition is in a form suitable for administration to the mucosal membranes of the nasal cavity, buccal cavity and/or respiratory tract, and the composition may not comprise liposomes, vesicles, micelles, or microemulsions. 2. A pharmaceutical composition comprising: a therapeutic agent selected from the group consisting of growth hormone and parathyroid hormone; and an absorption enhancer comprising polyethylene glycol 660 hydroxy fatty acid ester; wherein the composition is in the form of an aqueous solution or a dry powder that is suitable for administration to the mucosal membranes of the nasal cavity, buccal cavity and/or respiratory tract. 3. The composition according to claim 1, wherein the absorption enhancer further comprises free polyethylene glycol. 4. The composition according to claim 3, wherein the absorption enhancer comprises from about 30% to about 90% by weight of polyethylene glycol 660 hydroxy fatty acid ester, and from about 10% to about 50% by weight of free polyethylene glycol. 5. The composition according to claim 1, wherein the amount of absorption enhancer is at least 0.001% by weight of the total composition. 6. The composition according to claim 1, further comprising a bioadhesive agent, gelling agent and/or thickening agent. 7. The composition according to claim 1, wherein the pharmaceutical composition comprises one or more additional absorption enhancers. 8. The composition according to claim 7, wherein the additional absorption enhancer is selected from the group consisting of cyclodextrin, bile salts, poly-L-arginine, chitosan, phospholipids, lysophospholipids, polyacrylic acid, hyaluronic acids, sodium caprate and aminated gelatin. 9. The composition according to claim 2, wherein the composition is in the form of spray-dried or freeze-dried particles, microspheres or nanoparticles. 10. The composition according to claim 1, wherein the therapeutic agent is human growth hormone. 11. The pharmaceutical composition according to claim 2, wherein the therapeutic agent is human growth hormone. 12. The composition according to claim 1, wherein the amount of absorption enhancer present in the composition is at least 0.1% by weight of the total composition. 13. The composition according to claim 12, wherein the amount of absorption enhancer present in the composition is at most 40% by weight of the total composition. 14. The composition according to claim 13, wherein the amount of absorption enhancer present in the composition is 1 to 20% by weight of the total composition. 15. The composition according to claim 13, wherein the amount of absorption enhancer present in the composition is 2 to 15% by weight of the total composition. 16. The composition according to claim 13, wherein the amount of absorption enhancer present in the composition is 5 to 10% by weight of the total composition. 17. The composition according to claim 1, wherein the composition is in a form suitable for administration to the mucosal membranes of the nasal cavity and/or respiratory tract. 18. The composition according to claim 1, wherein the composition is in the form of a solution, gel, powder or nasal insert. 19. The composition according to claim 1, wherein the composition is in the form of a solution or dispersion in an aqueous medium, or a dry powder. 20. The composition according to claim 2, wherein the absorption enhancer further comprises free polyethylene glycol. 21. The composition according to claim 2, wherein the absorption enhancer comprises from about 30% to about 90% by weight of polyethylene glycol 660 hydroxy fatty acid ester, and from about 10% to about 50% by weight of free polyethylene glycol. 22. The composition according to claim 2, wherein the amount of absorption enhancer is at least 0.001% by weight of the total composition. 23. The composition according to claim 2, wherein the amount of absorption enhancer present in the composition is at least 0.1% by weight of the total composition. 24. The composition according to claim 23, wherein the amount of absorption enhancer present in the composition is at most 40% by weight of the total composition. 25. The composition according to claim 2, further comprising a bioadhesive agent, gelling agent and/or thickening agent. 26. The composition according to claim 2, wherein the pharmaceutical composition comprises one or more additional absorption enhancers. 27. The composition according to claim 26, wherein the additional absorption enhancer is selected from the group consisting of cyclodextrin, bile salts, poly-L-arginine, chitosan, phospholipids, lysophospholipids, polyacrylic acid, hyaluronic acids, sodium caprate and aminated gelatin.

Details for Patent 8,795,634

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015	⤷ Try a Trial	2028-09-12
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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